Nickett Donaldson-Kabwe, Ph.D., CCRA

GMP Operations Advisor

Nickett holds a Ph.D. in Cell & Molecular Biology with specialization in the molecular biology of cancer. As a seasoned molecular biologist, she studied gene expression, specifically, methylation and sequence specific DNA binding and regulation by POZ-Zinc Finger proteins involved in tumorigenic processes. She also holds certification in Clinical Research from McMaster University in Hamilton Ontario, and an honors Bachelor of Science in Biotechnology from Brock University in St. Catharines Ontario, where she focused on fungal pathology.

Nickett has over 10+ years of professional experience in GMP manufacturing of various products including starting materials, drug substances and drug products. Her GMP career began in the bio-pharmaceutical industry, where she operated small- and large-scale bioreactors during GMP manufacturing of recombinant therapeutic proteins to treat intestinal disorders.  She later worked in Quality Control, where she tested & released raw materials prior to use in manufacturing processes, and in-process samples & final drug products for use in clinical settings.  Additionally, she has experience executing assays to determine drug product stability and has conducted a plethora of product specific quality tests. Nickett’s experience extends to regulated cleanroom operations, where she engages in the design and qualification of cleanroom facilities. This includes validation of critical utilities such as HVAC, process gasses and water. Her experience extends to the successful implementation of cleanroom sanitation programs, of which she has implemented environmental monitoring programs for three companies and oversaw the daily operations of two clean room manufacturing facility. In her role as GMP Operations Manager, she established Sunnybrook’s GMP Cleanroom Facility (ISO-6 & 7 cleanrooms) from inception to operational state, overseeing the daily operations during the production of cell and gene therapy products (i.e., human pluripotent stem cell banks, mRNA vaccines and autologous & allogenic cell therapy). Some of her other experiences include establishing cleanroom Gown Qualifications, Aseptic Operator qualifications and Raw Material Management programs. Her experience extends to operating other cleanroom facility, in the capacity as Director of GMP Operations, where she oversees the qualification and maintenance of cleanrooms (ISO-6, -7 & 8) prior to use in manufacturing GMP microbial cell banks, plasmid DNA and mRNA, and implementation of quality programs to maintain contamination control.

Address

Calgary, Canada